ASEPTIC MANUFACTURING & DECONTAMINATION VALIDATION
Aseptic manufacturing (or sterile manufacturing as it is somethings referred to) is one of the most important parts of biopharmaceutical manufacturing. Due to the nature of the biopharmaceutical industry, sterility remains of the upmost importance in packaging product due to the potentially harmful impact it can have on the end user.
Aseptic manufacturing is used in instances whereby the stability of the drug or product would be affected through the use of dry heat ovens, Ethylene Oxide, steam autoclave, or irradiation (either E Beam or Cobalt 60 Gamma), which are all methods of terminal sterilisation. When terminal sterilisation is not appropriate, aseptic filling is used for a variety of biotech and pharmaceutical drugs.
Sterility requirements for syringes have only been around since the 1920s, and further requirements for the larger scale manufacturing of plasma and blood products were established as recently as World War II. Until that time, blood and plasma products underwent a pasteurisation process, which did nothing for providing sterility, but did reduce fungal contamination. It wasn’t until the 1980s that government regulatory bodies established requirements for aseptic manufacturing.
Though personnel within the cleanroom are essential to completing the aseptic manufacturing and fill process, they are also the biggest source of contaminants and pose the most microbial risk to the sterile environment. Though automated aseptic fill equipment can significantly reduce the amount of people present in the cleanroom, it cannot eliminate the need for human direction entirely. Personnel to be in the cleanroom at the time of aseptic filling and manufacturing need to be provided with a set of best practices training such as state hygiene, gowning and de-gowning, and other procedures to prevent further microbial contamination.
Personnel who work within the cleanroom core for aseptic fill / finishing will need to complete a gowning qualification to ensure that they know and understand the proper procedure. Each cleanroom will have their own standard of attire in keeping with the ISO grade of the room and the task carried out therein, and may include bouffant caps, shoes, face masks, beard covers, boots, gowns, aprons, gloves, frocks, hoods, and shoe covers.
Hydrogen peroxide (H2O2) is a powerful oxidant that is an effective steriliser of spore-forming bacteria. Commonly used as a vapour, hydrogen peroxide is used in aseptic manufacturing and filling within the food, pharmaceutical, and biotech industries where terminal sterilisation would affect the stability of the drugs or products. The verification of hydrogen peroxide decontamination has always traditionally been carried out through the use of biological indicators, though with delays in results and risks of false positives, biological indicators are quickly becoming a thing of the past thanks to new enzyme indicators. Enzyme indicators offer fast, cost effective, accurate, and risk free results for testing HPV sterilised aseptic chambers, isolators, and cleanrooms.
Reliable decontamination processes are crucial to aseptic manufacturing, as well as any industry that utilises cleanrooms. When contamination does occur, manufacturing processes can often be shut down for days while waiting on results from biological indicator tests to come back. Enzyme Indicators are revolutionising that process by providing instant, reliable, quantifiable results for lab and cleanroom decontamination processes. The thermostable enzyme Adenylate Kinase is a vastly superior decontamination monitor thanks to its reliable inactivation profile and its extremely high environmental tolerances. Adenylate Kinase undergoes a luciferin reaction, which can then be measured using a luminometer, thereby giving lab and cleanroom personnel instant, quantifiable data on their decontamination processes.
Chosen as the global exclusive commercialization partner for the Public Health England, Protak Scientific is leading the way with Enzyme Indicator technology. Thermostable Adenylate Kinase is currently working for various large pharmaceutical companies.
Protak Scientific is passionate about bringing this faster, reliable, accurate, and cheaper technology to the scientific community.